Depressive DisorderNCT04560192
Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination
A study testing Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU) and Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT) in people with Depressive Disorder and Depression, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
In this study the investigators are examining the neuronal processes of a mindfulness based emotion regulation training for reducing depressive rumination. The research of depressive rumination helps in the developement of new therapies for depressive disorders. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Depression, Rumination
- What is being tested?
- Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU) and Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18-60
- german as mother tongue
- diagnosis of a unipolar depressive disorder
- ruminative processes in the psychopathology
Who cannot join
- pregnancy
- acute or chronic disorder or medical treatment of such that might influence the cerebral metabolism:
- Diabetes mellitus (E10-E14 in ICD-10)
- Renal insufficiency apart from stadium 3 in Kidney Disease Outcomes Quality Initiative
- non adjusted hypertonus (I10.x in ICD-10)
- medium-severe or severe craniocerebral injury (GCS 3-12) / craniocerebral injury of 2. or 3. degree with loss of consciousness of > 30 minutes
Show all 11Show fewer
- any medication except oral contraceptives
- other axis-I / axis-II disorders as main diagnosis
- comorbid neurological disease
- psychotic symptoms
- acute suicidality \& very severe depressive symptomatology (BDI-II Score > 40)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, 72076
Hendrik Laicher, M. Sc., +49 7071 29-87103, hendrik.laicher@med.uni-tuebingen.de
David Rosenbaum, Dr., +49 7071 29-86309, david.rosenbaum@med.uni-tuebingen.de
About this study
Official title: Analysis of the Neuronal Correlates of a Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination Untersuchung Der Neuronalen Korrelate Eines Emotionsregulationstrainings Zur Behandlung Depressiven Grübelns
In this study the investigators are examining the neuronal processes of a mindfulness based emotion regulation training for reducing depressive rumination. The research of depressive rumination helps in the developement of new therapies for depressive disorders.
Goal of this project is to have a look at the coherences between stress, mindfulness resources, depressive rumination and their neuronal correlates. Therefore the investigators are collecting the data of 48 patients with a depressive diagnosis in a randomized intervention-study with a treatment as usual (TAU) waiting-control-list versus an active intervention group. An additional 48 healthy control subjects are planned to be measured.
Read the detailed description
In a randomized and (for gender and severity of depressive symptomatic) outbalanced design the investigators are examining the neuronal processes of a mindfulness based emotion regulation training (MBERT) for reducing depressive rumination in a cross-over design.
Therefore 48 patients with a depressive disorder get a MBERT that consists of one psychoeducative session and 8 therapy sessions.
For checking the efficacy of the MBERT each patient runs three times through the Trier Social Stress Test (TSST). As the study design is a cross-over design, half of the patients get the MBERT in block 1 (i.e. between the first and the second TSST) and half of the patients get the MBERT in block 2 (i.e. between the second and the third TSST). In the block where they don't receive the MBERT the patients don't get any treatment within the scope of the study (waiting period), but any treatment as usual (TAU), including pharmacotherapy and psychotherapy, can be continued and started at each point of the study.
For analyzing the neuronal processes the investigators are measuring the cerebral oxygenation using functional near-infrared-spectroscopy (fNIRS) during the TSSTs as well as during the 8 therapy sessions.
Using an ecological momentary assessment (EMA), the investigators additionally are collecting data of the actual stress level, stressful events, rumination, equanimity, self-compassion, mindfulness and sleep quality two times a day. Thus the investigators can (1) observe the individual reaction to stress in the daily life, and (2) recheck if the patients are able to transfer the learned strategies from the MBERT in their daily life. For those patients that received the MBERT in the first block the investigators (3) additionally have data to evaluate the sustainability (i.e. the lasting effectivity) of the MBERT.
As a control condition, 48 healthy subjects will get a single TSST session.
- Conditions
- Depressive Disorder, Depression, Rumination
- Being tested
- Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU), Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)
- Keywords
- fNIRS, Rumination, Depression, Momentary Assessment, TSST, Emotion regulation therapy, Mindfulness based
- Medical subject headings
- Depressive Disorder, Depression, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)Behavioural
- In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation.
- Waiting period with TAU.
Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)Other
- Waiting period with TAU.
- In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Treatment with the mindfulness based emotion regulation therapy (MBERT) in block 1, no study-treatment in block 2 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy). Receives: Behavioral: Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU) |
| Treatment as usual (TAU) | Other | No study-treatment in block 1 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy), treatment with the mindfulness based emotion regulation therapy (MBERT) in block 2. Receives: Other: Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT) |
| Control condition | No intervention | Healthy subjects will get a single TSST session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-compassion-scale (SCS)
Changes in self compassion through the mindfulness based emotion regulation therapy. Minimum value: 1; maximum value: 5; higher values mean better self compassion (i.e. a better outcome).
Measured: 8-10 weeks
Becks Depression Inventory (BDI)
Changes in depressive symptomatic through the mindfulness based emotion regulation therapy. Minimum value: 0; maximum value: 63; higher values mean more severe depressive symptoms (i.e. a worse outcome).
Measured: 8-10 weeks
TSST
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
Measured: 3 times in 8-10 weeks
state rumination
Changes in state rumination while and immediately after the stress induction via the Trier Social Stresstest; increase from pre to post TSST
Measured: 3 times in 8-10 weeks
Secondary outcomes (4)
fNIRS TSST activation
Hemodynamic response / brain activation while control tasks and the stress induction via the Trier Social Stresstest
Measured: 3 times in 8-10 weeks
fNIRS Training activation
Hemodynamic response / brain activation while the mindfulness based emotion regulation therapy / training sessions
Measured: 8 times in 4-5 weeks
Training rating scores
Friendliness (with oneself and ones emotions) as well as emotional distancing while the mindfulness based emotion regulation therapy / training sessions via single questions after each trial. Ratings range from 0 to 9, while the higher the score the more the friendliness or the emotional distancing (i.e. higher scores mean a better outcome).
Measured: 8 times in 4-5 weeks
Electronical momentary assessment (EMA)
Self compassion, rumination, mindfulness, subjective stress and sleep quality in the daily routine (recorded via momentary assessment). Therefore items from different questionnaires (Self compassion scale (SCS), Ruminative Response Scale (RRS), Perseverative Cognitions Questionnaire (PCQ)) and self created items were taken. For self compassion, rumination and mindfulness mean scores can be calculated afterwards (self compassion: min: 0, max: 100; rumination \& mindfulness: min: 0, max: 5; for self compassion and mindfulness higher scores mean a better outcome, for rumination higher scores mean a worse outcome).
Measured: 2 times per day in 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann-Christine Ehlis, Dr., Study chair, submitter and head of the lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560192
- Sponsor's protocol ID
- 159/2018BO1
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers can get IPD of interest after request.
Publications
Laicher H, Int-Veen I, Woloszyn L, Wiegand A, Kroczek A, Sippel D, Leehr EJ, Lawyer G, Albasini F, Frischholz C, Mossner R, Nieratschker V, Rubel J, Fallgatter A, Ehlis AC, Rosenbaum D. In situ fNIRS measurements during cognitive behavioral emotion regulation training in rumination-focused therapy: A randomized-controlled trial. Neuroimage Clin. 2023;40:103525. doi: 10.1016/j.nicl.2023.103525. Epub 2023 Oct 13.
PubMed 37839195
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Neuronal Correlates of a Mindfulness Based Emotion Regulation Therapy in the Treatment of Depressive Rumination Untersuchung Der Neuronalen Korrelate Eines Emotionsregulationstrainings Zur Behandlung Depressiven Grübelns
- ClinicalTrials.gov ID
- NCT04560192
- Acronym / sponsor ID
- 159/2018BO1
- Conditions
- Depressive Disorder, Depression, Rumination
- Keywords
- fNIRS, Rumination, Depression, Momentary Assessment, TSST, Emotion regulation therapy, Mindfulness based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators are examining the neuronal processes of a mindfulness based emotion regulation training for reducing depressive rumination. The research of depressive rumination helps in the developement of new therapies for depressive disorders.
Goal of this project is to have a look at the coherences between stress, mindfulness resources, depressive rumination and their neuronal correlates. Therefore the investigators are collecting the data of 48 patients with a depressive diagnosis in a randomized intervention-study with a treatment as usual (TAU) waiting-control-list versus an active intervention group. An additional 48 healthy control subjects are planned to be measured.
Detailed description
In a randomized and (for gender and severity of depressive symptomatic) outbalanced design the investigators are examining the neuronal processes of a mindfulness based emotion regulation training (MBERT) for reducing depressive rumination in a cross-over design.
Therefore 48 patients with a depressive disorder get a MBERT that consists of one psychoeducative session and 8 therapy sessions.
For checking the efficacy of the MBERT each patient runs three times through the Trier Social Stress Test (TSST). As the study design is a cross-over design, half of the patients get the MBERT in block 1 (i.e. between the first and the second TSST) and half of the patients get the MBERT in block 2 (i.e. between the second and the third TSST). In the block where they don't receive the MBERT the patients don't get any treatment within the scope of the study (waiting period), but any treatment as usual (TAU), including pharmacotherapy and psychotherapy, can be continued and started at each point of the study.
For analyzing the neuronal processes the investigators are measuring the cerebral oxygenation using functional near-infrared-spectroscopy (fNIRS) during the TSSTs as well as during the 8 therapy sessions.
Using an ecological momentary assessment (EMA), the investigators additionally are collecting data of the actual stress level, stressful events, rumination, equanimity, self-compassion, mindfulness and sleep quality two times a day. Thus the investigators can (1) observe the individual reaction to stress in the daily life, and (2) recheck if the patients are able to transfer the learned strategies from the MBERT in their daily life. For those patients that received the MBERT in the first block the investigators (3) additionally have data to evaluate the sustainability (i.e. the lasting effectivity) of the MBERT.
As a control condition, 48 healthy subjects will get a single TSST session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)Treatment with the mindfulness based emotion regulation therapy (MBERT) in block 1, no study-treatment in block 2 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy). |
| Treatment as usual (TAU) | Other | Other: Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)No study-treatment in block 1 (but patients receive their possibly already started treatment as usual including pharmacotherapy and psychotherapy), treatment with the mindfulness based emotion regulation therapy (MBERT) in block 2. |
| Control condition | No intervention | –Healthy subjects will get a single TSST session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age: 18-60
- german as mother tongue
- diagnosis of a unipolar depressive disorder
- ruminative processes in the psychopathology
Key exclusion criteria (11 listed)
- pregnancy
- acute or chronic disorder or medical treatment of such that might influence the cerebral metabolism:
- Diabetes mellitus (E10-E14 in ICD-10)
- Renal insufficiency apart from stadium 3 in Kidney Disease Outcomes Quality Initiative
- non adjusted hypertonus (I10.x in ICD-10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)1. In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation. 2. Waiting period with TAU. | Behavioural | Intervention group |
| Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)1. Waiting period with TAU. 2. In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation. | Other | Treatment as usual (TAU) |
Primary outcome
Self-compassion-scale (SCS)
Time frame: 8-10 weeks
Changes in self compassion through the mindfulness based emotion regulation therapy. Minimum value: 1; maximum value: 5; higher values mean better self compassion (i.e. a better outcome).
Becks Depression Inventory (BDI)
Time frame: 8-10 weeks
Changes in depressive symptomatic through the mindfulness based emotion regulation therapy. Minimum value: 0; maximum value: 63; higher values mean more severe depressive symptoms (i.e. a worse outcome).
TSST
Time frame: 3 times in 8-10 weeks
Changes in behavior while and immediately after the stress induction via the Trier Social Stresstest
state rumination
Time frame: 3 times in 8-10 weeks
Changes in state rumination while and immediately after the stress induction via the Trier Social Stresstest; increase from pre to post TSST
4 secondary outcomes
fNIRS TSST activation
Time frame: 3 times in 8-10 weeks
fNIRS Training activation
Time frame: 8 times in 4-5 weeks
Training rating scores
Time frame: 8 times in 4-5 weeks
Electronical momentary assessment (EMA)
Time frame: 2 times per day in 8-10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 37839195Laicher H, Int-Veen I, Woloszyn L, Wiegand A, Kroczek A, Sippel D, Leehr EJ, Lawyer G, Albasini F, Frischholz C, Mossner R, Nieratschker V, Rubel J, Fallgatter A, Ehlis AC, Rosenbaum D. In situ fNIRS measurements during cognitive behavioral emotion regulation training in rumination-focused therapy: A randomized-controlled trial. Neuroimage Clin. 2023;40:103525. doi: 10.1016/j.nicl.2023.103525. Epub 2023 Oct 13.
- Individual participant dataSharing planned: Yes. Other researchers can get IPD of interest after request.
Related trials for Depressive Disorder
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann-Christine Ehlis, Dr. study chair
submitter and head of the lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU) and Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT) in people with Depressive Disorder and Depression, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hendrik Laicher, M. Sc. (+49 7071 29-87103, hendrik.laicher@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-compassion-scale (SCS) (time frame: 8-10 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04560192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.